Guides & Documents
GMP Auditor Association
ECA Good Practice Guide –
GMP Auditors Reference Handbook
NEW: Version 4.0; April 2026
ECA Good Practice Guide –
GMP Auditors Reference Handbook
– Attachment 1: Audit Agenda Template –
Version 3.0; May 2025
ECA Good Practice Guide –
GMP Auditors Reference Handbook
– Attachment 2: Audit Report Template –
Version 3.0; May 2025
ECA Good Practice Guide –
GMP Auditors Reference Handbook
– Attachment 3: Audit Areas and Criteria –
NEW: Version 4.0; April 2026
Please visit the GMP Auditor Association website members' area to download the guides.
ATMP Group
Please visit the ATMP Group website members' area to download the guides.
Position Paper
– Reflections on specifications for ATMPs, considering patient-centricity –
Version 1.0; March 2026
European QP Association
EQPA Code of Practice for QPs
– Duties and Responsibilities for Qualified Persons in the EU –
Version 11.0; December 2024
EQPA Code of Practice for QPs
– Duties and Responsibilities for Qualified Persons in the EU –
Annex on National QP Implementation
Version 2.0; December 2024
Please visit the European QP Association website members' area to download the guides.
GDP Association
Good Distribution Practice
Guidance on interpretation and implementation
Version 4.0; March 2018
GOOD DISTRIBUTION PRACTICE FOR ACTIVE
SUBSTANCES
Guidance on interpretation and implementation
Version 4.0; March 2018
Code of Practice
The Responsible Person for GDP
Version 2.0; November 2018
Please visit the GDP Association website members' area to download the guides.
Analytical Quality Control Group
Laboratory Data Management Guidance
– Sampling and Sample Management –
Version 1.0; April 2025
Guide for an Integrated Lifecycle
Approach to Analytical Instrument
Qualification and System Validation
Version 1.0; November 2023
GMP, GCP and GDP
Data Governance and
Data Integrity
Version 3.0; December 2022
STANDARD OPERATING PROCEDURE
Laboratory Data Management;
Out of Specification (OOS) Results
Version 2.1; August 2013
LABORATORY DATA MANAGEMENT GUIDANCE
Out of Expectation (OOE)
and Out of Trend (OOT) Results
Version 1.2; July 2013
Please visit the Analytical Quality Control Group website members' area to download the guides.
ECA Pharmaceutical Microbiology Group
Bioburden – Regulatory
Expectations and Experiences
Questions & Answers
Version 2.0; October 2025
Guidelines for the Evaluation and Investigation of
Microbiological Deviations
Version 1.0; June 2021
Please visit the Pharmaceutical Microbiology Group website members' area to download the guides.
ECA Validation Group
Good Practice Guide
Qualification and Validation
A guide to effective qualification based on custumer-supplier partnership
Vesrion 3.0; November 2024
Validation Good Practice Guide
Vesrion 2.0; 2015
Please visit the Validation Group website members' area to download the guides.
ECA Visual Inspection Group
Visual Inspection of Medicinal
Products for Parenteral Use
Version 5.0; October 2025
Container Closure Integrity Testing of
Medicinal Products for Parenteral Use
– Position Paper –
Version 3.0; November 2025
Please visit the Visual Inspection Group website members' area to download the guides.
Data Integrity & IT Compliance Group
GMP, GCP and GDP
Data Governance and
Data Integrity
Version 3.0; December 2022
STANDARD OPERATING PROCEDURE
Selection Process for Cloud Service Providers
Audit Checklist
PaaS Cloud Service Providers
Audit Checklist
SaaS Cloud Service Providers
Please visit the Data Integrity & IT Compliance Group website members' area to download the guides.
ECA CCS Task Force
How to Develop and Document a Contamination
Control Strategy
Version 2.0; December 2022
Please pelase see the ECA Foundation news section to download the guides.
ECA Cannabis Group
Cannabis Road Map
Version 8.0; 2024